Impact of the Age Difference Between the Donor and Recipient on the Morbidity and Mortality After Lung Transplantation. Study on a National Multicenter Cohort (COLT)

NCT02855372 | Unknown

• 1 other identifier: 2015-39
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

It is commonly accepted that the characteristics of the organ donor impact on the future post transplant. In lung transplantation (LP), the defining characteristics of the "ideal" donor includes an age less than 55 years. However, before the pulmonary graft shortage with a corresponding mortality still too high waiting list, the lung graft acceptance criteria were reassessed permitting criteria "extension" ( "marginal" graft). And were grafted, depending on the urgency and accessibility problems in the registry of potential candidate, organs from donors aged 55 and older with quite comparable to those obtained from younger donors . Nevertheless, it is common practice that the grafts from older donors are more readily allocated to older candidates and the most severe, as many confounding factors to assess the real impact of donor age on post-transplant evolution on small cohorts. The main goal of this study is to compare the survival of lung transplant patients depending on the age difference between donor and recipient. The study will be conducted from a broad national cohort of lung transplant patients registered in COLT ( Lung Transplantation COhort). Established in September 2009, promoted by the University Hospital of Nantes, COLT involves 11 lung transplant centers authorized on French territory. It provides a standardized common longitudinal monitoring of the recipient from his transplant. Currently more than 1,000 patients included in this study are transplanted.

Conditions

Lung Transplantation

Outcome Measures

Primary Outcomes (1)

• Age difference in years between donor and recipient

  The age difference will then be able to define two groups of patients: * 1 group with an age difference \< 10 years * 1 group with an age difference \> 10 years

  1 day

Study Arms (1)

Lung transplanted patients

Procedure: Lung transplantation

Interventions

Lung transplantation PROCEDURE

Lung transplanted patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient who underwent a lung transplantation

You may qualify if:

• Male or female adult patients, included in COLT cohort, thus having given a signed written consent
• Who received a lung transplant

You may not qualify if:

• Lung transplanted patients in a context of national priority
• Lung transplanted patients who died within 3 months after the surgery
• Patients for whom it is a second lung transplantation

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille, Hôpital Nord

Marseille, 13915, France

Location

MeSH Terms

Interventions

Lung Transplantation

Intervention Hierarchy (Ancestors)

Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Catherine GEINDRE

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Central Study Contacts

Urielle DESALBRES

CONTACT

04 91 38 20 61; urielle.desalbres@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 4, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: April 1, 2018
• Last Updated: August 4, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)